Duns Number:045623154
Device Description: The Multi-Analyte Chemistry calibrator is for use as a calibrator of Pointe Scientific Inc The Multi-Analyte Chemistry calibrator is for use as a calibrator of Pointe Scientific Inc. clinical chemistry assays. This calibrator material is well suited for automated and semi-automated analytical procedures.
Catalog Number
C7506-50
Brand Name
POINTE SCIENTIFIC Chemistry Calibrator
Version/Model Number
C7506-50
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K070207
Product Code
JIX
Product Code Name
Calibrator, Multi-Analyte Mixture
Public Device Record Key
d8270875-2843-47b9-bac0-1c6d6f1b8ff9
Public Version Date
December 21, 2020
Public Version Number
4
DI Record Publish Date
August 31, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 217 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 455 |
| U | Unclassified | 2 |